NCT00004748

Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC). II. Determine the optimum dose and duration of MTX treatment. III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by prior/concurrent medical management. Patients in the first group are treated with oral methotrexate 3 times a week and a daily oral placebo. Patients in the second group are treated with daily oral colchicine and an oral placebo 3 times a week. Therapy continues for 10 years. Beginning year 2, daily oral ursodiol is administered to all patients. Patients with disease progression are crossed to the alternate group or undergo liver transplantation if clinically indicated.

Conditions

• Liver Cirrhosis, Biliary

Interventions

Type	Name	Description
DRUG	colchicine
DRUG	methotrexate
DRUG	ursodiol

Timeline

• Start date: 1989-11-01
• First posted: 2000-02-25
• Last updated: 2005-06-24